OLAW Online Seminar March 12, 2020

Ted Myatt, Sc.D., University of Rhode Island

Eileen Morgan, NIH, Office of Laboratory Animal Welfare

Building a Research Occupational Health Program

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OLAW FAQ G.9.: olaw.nih.gov/guidance/faqs#G

OLAW Online Seminar March 12, 2020

Ted Myatt, Sc.D., University of Rhode Island

Eileen Morgan, NIH, Office of Laboratory Animal Welfare

Building a Research Occupational Health Program

Occupational Health and Safety Programs

Eileen MorganDirector, Division of Assurances Office of Laboratory Animal WelfareNational Institutes of Health (NIH)

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Objectives

Identify Occupational Health and Safety Program (OHSP) requirements per PHS Policy and Guide

Indicate who is responsible for the OHSP

Identify essential components of an effective OHSP

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Requirements

PHS Policy IV.A.1.f.For institutions with an Animal Welfare Assurance, the Institutional Program for Animal Care and Use must include a description of … “the health program for personnel who work in laboratory animal facilities or have frequent contact with animals”

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RequirementsGuide for the Care and Use of Laboratory Animals, 2011 (p 17-23)

“Each institution must establish and maintain an occupational health and safety program (OHSP) as an essential part of the overall Program of animal care and use.”

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RequirementsMedical Evaluation and Preventative Medicine for Personnel• “…development and implementation of a

program of medical evaluation and preventive medicine should involve input from trained health professionals, such as occupational health physicians and nurses.”

• “Confidentiality and other medical and legal factors must be considered…”

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Polling Q1

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Components of an OHSP

• Personnel Training• Disaster Planning/Emergency Preparedness • Risk Assessment• Medical Treatment• Facilities, Equipment & Monitoring• Hazard Identification• Health Assessment• Personal Protection

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Risk Assessment is anEssential Component

Two parts to the risk assessment process include:

• Identifying hazards associated with risks of the job

• Identifying risks of the individual

Occupational Health and Safety in the Care and Use of Research Animals, National Research Council, 1997 11

OLAW FAQ G.2. What is Required?

Pre-placement medical evaluation

Identification of hazards to personnel and safeguards appropriate to the risks associated with the hazards

Appropriate testing and vaccinations Training of personnel regarding their duties, any hazards, and necessary safeguards

Personal protective equipment (PPE)

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OLAW FAQ G.2. What is Required?

Policies and facilities that promote cleanliness

Provisions for treating and documenting job-related injuries and illnessesFacilities, equipment and procedures designed, selected and developed to reduce the possibility of physical injury or health risk to personnelGood personal hygiene practices, prohibiting eating and drinking, use of tobacco products, and application of cosmetics and contact lenses in animal rooms and laboratories

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Summary

• The institution is responsible for establishing and maintaining an effective OHSP

• The nature of the OHSP will depend on the facility, research, hazards, and species involved …beginning with an identification of those hazards and assessment of the associated risks

• An effective OHSP requires evaluation of program components and the coordination of various research, program, administrative, and facility personnel

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Building an Effective Research Occupational Health Program

Ted Myatt, Sc.D.Associate Vice President for Research Administration

University of Rhode Island

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Requirements for an Occupational Health and Safety Program (OHSP)PHS Policy IV.A.1.f.For institutions with an Animal Welfare Assurance, the Institutional

Program for Animal Care and Use must include a description of “the health program for personnel who work in laboratory animal facilities or have frequent contact with animals.”

Guide for the Care and Use of Laboratory Animals (p. 17)“Each institution must establish and maintain an occupational health

and safety program (OHSP) as an essential part of the overall Program of animal care and use.”

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Health Risks of Animal Care StaffVeterinary services rank 2nd in incidence rates for non-fatal occupational injuries and illnesses

Types of injuries or illnesses:Laboratory animal allergies, with progression to asthma

• 10-46% of exposed develop allergiesNeedlestick/sharps injuries Musculoskeletal disorders (MSDs)Compassion fatigue, stress, burnoutZoonotic infectious disease

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Topics for Today

Confront the barriers

Improve upon what you have

Be inclusiveGo beyond the GuideConsider the broader research community

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Challenges and Barriers to an Effective OHSP

Lack of expertiseLack of resources Institutional barriersOn-campus health services focused on student health only

OHSP focused on clinical care, not research environment

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Polling Q2

What Does Your OHSP Need to be?

“The nature of the OHSP will depend on the facility, research, hazards, and species involved.” (Guide, p. 17)

Start by evaluating the risks

Conduct an assessment of all activities involving animals

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Building an Effective Program

Based on your risks, understand program needs (i.e., time, resources)It’s OK to start small Utilize outsourced expertise wiselyBuild in training opportunities

Program needs champions Leadership and doers

Regardless of size, a successful program requires a team approach

Hallmark of an Effective Program?

Sound Implementation Strategies

Focus on developing sound, realistic policies and

procedures

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Engage Leadership Gain Support

EngageProactively discuss regulatory requirements and risks with senior leadership

Data – conduct a gap assessment Internal or externalCompare against requirements and

peer institutionsSurvey program usersRate status of program areas

(e.g., not present, developing, mature)

Hallmark of an Effective Program?

Strong Administrative Support

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Challenge – Lack of a Broader OHSP

No on-site occupational health programList of providers as opposed to an occupational program to

“integrate” intoUrgent care is first line of treatmentState-run programs Connect with institutional risk management

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Example SituationGrowing Research Institution

No on-site occupational health serviceNo occupational health expertise in-houseUsed biomedical research focused occupational health consultant

to provide remote support (i.e., medical evaluations)Used consultant to train in-house staff

Gradually expanded in-house programs

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Be EfficientUse available capabilities

and services

Use Health Services electronic medical records system for animal contact medical surveillance and respiratory protection medical evaluation

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Improve Your OHSP – Learn, Grow, EvolvePrograms should be ever changingSemiannual IACUC program review is a good mechanism for

self-evaluation

Identify funds for training opportunities

Improve your logisticsMake interacting with the program as easy as possible – consider the

researcher’s perspectiveCan communication between offices be improved?Interact with Human Resources to connect immediately with new hiresInteract with Enrollment Services to obtain student rosters for classes

that involve animal contact27

Be Inclusive – Go Beyond the Guide

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

OSHA Standards• 29 CFR 1910.1030 Bloodborne Pathogens• 29 CFR 1910.95 Occupational Noise Exposure• 29 CFR 1910.1048 Formaldehyde• 29 CFR 1910.1450 Laboratory Standard

Nuclear Regulatory Commission Standards and Regulations

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Include Everyone

Protections for: • pregnant women; • immunocompromised

individuals; and • People not involved with the

animal care and use program (e.g. visitors, students, maintenance workers, emergency workers)

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• Ensure your institution does not limit services to those with animal contact

• What about staff or students that do not have contact with animals?

What Does a Program Look Like?

Animal ExposureMedical surveillance program, health history questionnaire,

tetanus vaccinationEmployees who handle wild animals will be provided rabies

vaccinations

Biological MaterialsLaboratory workers who handle pathogens for which there is an

effective vaccine available will be provided vaccinations for those agents

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Reproductive ConcernsLaboratory workers who handle materials for which exposure may

result in potential reproductive and developmental concerns will be provided risk evaluation and medical advice

Respiratory ProtectionLaboratory staff may necessitate the use of a respirator due to medical

considerations or exposure to allergens or hazardous materialsConnect with EH&S to provide fit testing

Other Occupational Injuries31

What Does a Program Look Like?

Example SituationClinical Care Focused Occupational Health Program

Robust clinical care occupational health programLarge research program Beyond basic support for animal care staff (i.e., allergen exposures),

there was a lack of understanding of other occupational risks

Work to incorporate research issues into larger occupational health programEngaged OHSP team to participate in research-related functions to

learn about research health risks (e.g., attending IBC, IACUC)Established lines of communication with local emergency

department to facilitate care the event of exposures32

Improve Your OHSP

Continue to develop resourcesMedical SOPs for health

providersAgent specific training, hazard

specific training

Expand to new areasErgonomic evaluations

Hallmark of an Effective Program?

Ensure Coordination of Program Components

Meet regularly with stakeholders

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Build Awareness

IACUC policy requires participationIACUC research protocols and courses

that involve exposure to animals

IBC policy Communications with faculty, staff,

and studentsWebsite, flyers, and magnets

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Involve the Community Gain Support

Demonstrate the value of the OHSPPublish annual progress reports

Ask for feedback

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Questions Submit to the chat box in the GoToMeeting control panel

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Question 1 Can you provide possible approaches or options that Assured Institutions may implement regarding completion of a medical evaluation?

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Question 2 My institution involves using animals in teaching. What is the expectation for the oversight of the students in an OHSP?

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Question 3 Part I

A PI considering writing his own IACUC training protocol for rodents. It involves participants who will observe the procedure and others who will have an opportunity to perform hands-on surgical procedures. What are the Occupational Health requirements for participants observing animal procedures and for participants manipulating or performing the animal procedures? 39

Question 3 Part II

What is the most effective composition of the Occupational Health Program that would be amenable for a small university with few resources (e.g., no adjunct medical school)?

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Question 3 Part III

What are the different models that universities use to fulfill NIH requirements (e.g., external contracts, relationship with hospitals)?

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Question 3 Part IV

Who is responsible for ensuring that there is an Occupational Health Program and where does this program fit in the structural organization of the institution?

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Question 4 How can institutions and their IACUCs best prepare for a coronavirus pandemic?

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Question 5Part I

Can OLAW provide guidance to institutions that are unable to conduct semiannual facility inspections at least once every 6 months as a result of a complete shutdown due to COVID-19 and/or where only essential personnel are allowed into facilities? 44

Question 5Part II

If OLAW authorizes a waiver regarding conducting semiannual facility inspections within the 6 month timeframe as a result of COVID-19, will institutions be allowed to “pick up where they left off” or will they be required to “catch up”? 45

Question 6If procedures on an IACUC-approved activity cannot be performed (e.g., administration of post procedural analgesia) as a result of a facility closure due to COVID-19, would that be considered reportable noncompliance to OLAW?

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Question 7 What should institutions do in the event surgical masks or N95 respirators are not available for purchase due to shortages?

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CDC Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings:

cdc.gov/noish/topics/hcwcontrols/recommendedguidanceextuse.html

CDC Strategies for Optimizing the Supply of N95 Respirators

cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html

Question 8 What provisions should be made if an institution is unable to provide the support, resources, or services to maintain a compliant animal care and use program (e.g., shortage of available animal care personnel)?

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Question 9 We have students that take classes on a farm. How should we handle their occupational health needs?

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Question 10We are almost finished with our Assurance renewal writing for submission, but with our institution is preparing for a shut-down/slow-down due to COVID-19, my fear is that it may not be submitted to OLAW in a timely manner. Is there any accommodation for business that is “not as usual”?

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Questions Submit to the chat box in the GoToMeeting control panel

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OLAW Online Seminar June, 11 2020

Animal Research and Public Support: A 2020 Vision for Strategic Communications

and Micro-Messaging

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